Zinc and probiotics to enhance immunogenicity of oral vaccines

Phase 4

Completed

• Conditions: Immunization

• Registration Number: CTRI/2012/05/002677
• Lead Sponsor: Department of Biotechnology

Brief Summary

This single center,double blind, double-dummy, placebo controlled, randomized parallel clinicaltrial with four groups will enroll approximately 560 total study participantsat approximately 5 weeks of age residing in proximity to the Christian MedicalCollege in Vellore.  As part of theparallel design, study participants will be randomized to one of the fourgroups following a 1:1:1:1 allocation to receive zinc supplement and probiotic supplement(N=140), zinc supplement and probiotic placebo (N=140), zinc placebo andprobiotic supplement (N=140), or zinc placebo and probiotic placebo(N=140). Serum specimens collected at 6 and 14 weeks will be analyzed for anti-rotavirus IgA and for neutralizing antibodies to poliovirus type 3 in order to determine whether or not supplementation with probiotics and/or zinc can enhance the proportion of children who respond to oral vaccination by at least  15%.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-07
• Last Update Posted: 2013-07-07

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 560

Inclusion Criteria

• •Infants 35-41 days old.
• •Live in area under surveillance.
• •Current weight ≥3.2 kg.
• •No syndromic evidence of immunocompromise.
• •No prior illness requiring hospitalization.
• •No current medical condition as determined by medical doctor which precludes study involvement.
• •Available for follow up for duration of study (through approximately 14 weeks of age).
• •Parents/guardians of infant are able to understand and follow study procedures and agree to participate in the study by providing signed informed consent.

Exclusion Criteria

• •Child has history of atopic symptoms.
• •Child has a known digestive system defect.
• •Child has history of chronic diarrhea.
• •Child has received a prior dose of rotavirus vaccine.
• •Child has received a prior dose of polio vaccine (beyond the birth dose).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•To evaluate the serologic immune response to rotavirus vaccine among Indian infants receiving zinc supplementation or a probiotic given daily for a week prior to the first dose through a week following the second dose of oral rotavirus vaccine compared to those receiving a zinc or probiotic placebo	4 weeks after the second dose of immunization

Secondary Outcome Measures

Name	Time	Method
•To evaluate the serologic immune response to oral polio vaccine among Indian infants receiving zinc or probiotic supplementation given daily for a week prior to the administration of the first dose through a week following the second dose of oral polio vaccine compared to those receiving a zinc or probiotic placebo	4 weeks after the second dose of immunization

Trial Locations

Locations (1)

Christian Medical College; 🇮🇳 Vellore, TAMIL NADU, India

Christian Medical College

🇮🇳Vellore, TAMIL NADU, India

Gagandeep Kang

Principal investigator

gkang@cmcvellore.ac.in